Evaluate the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Type 2 Diabetic Patients With Dyslipidemia

Condition(s) targeted: Diabetes Mellitus; Dyslipidemia

Intervention: Rosuvastatin (Drug); Simvastatin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Taipei Veterans General Hospital,Taiwan

Official(s) and/or principal investigator(s):
Chii-Min Hwu, MD, Principal Investigator, Affiliation: Taipei Veterans General Hospital,Taiwan
Wayne H Sheu, MD,phD, Principal Investigator, Affiliation: Taichung Veterans General Hospital
Chieh-Hsiang Lu, MD, Principal Investigator, Affiliation: Chia-Yi Christian Hospital

This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is superior to simvastatin 40 mg in achieving the combined goal of LDL-C (<100 mg/dL) and non-HDL-C (<130 mg/dL).

Official title: A Phase IV, Randomized, Open-Label, Parallel-Arm, Comparative and Forced- Titration Study to Compare the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Patients With Type 2 DM and Dyslipidemia

Study design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The percentage of patients achieving the combined treatment goal of LDL-C < 100mg/dl and non-HDL-C < 130 mg/dl at week 12 with rosuvastatin treatment compared with simvastatin treatment

Secondary outcome:

Achieving the combined treatment goal of LDL-C (<100 mg/dL) and non-HDL-C (130 mg/dL) at week 4;

Percentage of patients achieving the LDL-C goal of <100 mg/dL at week 4 and week 12;

Percentage of patients achieving the LDL-C goal of ＜70 mg/dL at Week;The mean percent change from baseline in lipid profile at week 4 and week 12;

Detailed description: The duration of patient participation will be 18 weeks consisting of a 1-week screening period, a 5-week lead-in period, followed by a 12-week treatment period.

Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Male and female between the ages of 20-75 years.

2. Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control.

3. Diagnosed with type 2 diabetes mellitus.

4. Fasting triglyceride ≧150 mg/dL ≦500 mg/dL or Non-HDL-C≧130,but≦200 mg/dL

5. Patients receiving stable antidiabetic treatment for 8 weeks before randomization (no change in the category of anti-diabetic agents, but the dose is adjustable).

6. All patients give written informed consent.

Exclusion Criteria:

1. A history of hypersensitivity to statins.

2. A history of rhabdomyolysis or hereditary muscle disorders.

3. Insulin-treated patients.

4. Patient with any conditions of acute or chronic pancreatitis.

5. Creatine kinase ≧3-fold upper limit of normal (ULN).

6. Patients with an estimated creatinine clearance (see note)≦30 ml/min or bilirubin ≧1. 5-fold ULN, or chronic active hepatitis or liver function impairment (AST and ALT ≧3-fold ULN).

7. Overt proteinuria (repeat spot urine protein >300mg/dl by dipstick method).

8. Patients are taking cyclosporine.

9. A history of homozygous familial hypercholesterolemia or familial dysbetalipoproteinemia.

10. Patients with alcohol and drug abuse in past 3 years.

11. Serious or unstable medical or psychological conditions.

12. Hypothyroidism (TSH > 5 μIU/mL).

13. In the investigator's opinion, continuation in the study would be detrimental to the patient's well-being or might confound the clinical trial.

Taipei Veterans General Hospital, Taipei, Taiwan

Taichung Veterans General Hospital, Taichung, Taiwan

Chia-Yi Christian Hospital, Chia-Yi, Taiwan

Starting date: June 2006
Ending date: June 2008
Last updated: February 19, 2008